Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations
Public ClinicalTrials.gov record NCT04391036. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Double-Blind Cross-Over Study of Self-Insertion of Two Formulations of a Placebo Vaginal Film
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a double-blinded crossover study to evaluate whether Eudragit® content impacts the ability to self-insert placebo vaginal films. Thirty women will self-insert one high and and one low Eudragit® content film. The insertion order will be randomized in a 1:1 ratio. After inserting each film, participants will complete a survey reporting their perceptions and experience. The primary endpoint is successful insertion defined as all of the film inside the vagina upon visual assessment by a study clinician. Secondary outcomes include preference for the low level or high level Eudragit® formulation film with respect to insertion and participants' description of identified challenges.
Study identification
- NCT ID
- NCT04391036
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 13, 2020
- Primary completion
- Oct 25, 2020
- Completion
- Oct 25, 2020
- Last update posted
- Feb 21, 2022
2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Pittsburgh, Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04391036, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 21, 2022 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04391036 live on ClinicalTrials.gov.